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Study to Describe the Actual Situation of Hepatitis C Treatment in Brazil (PICTURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02773394
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.

Study Description
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Brief Summary:
The purpose of the study is to describe: 1) the clinical profile, past and current management of participants with hepatitis C in Brazil reference centers; 2) the current situation about demographics characteristics, liver disease progression and clinical outcomes in Brazilian Hepatitis C virus (HCV) participants naive, in treatment and previously exposed to antiviral treatment without sustained virological response (SVR).

Condition or disease
Hepatitis C Virus

Detailed Description:
This is an observational, non-interventional, cross-sectional, multicenter study to describe demographic characteristics, treatment performed and clinical outcomes of Brazilian participants with HCV chronic infection in about 12 Brazilian reference centers. It will expect that approximately 2000 participants will be enrolled in the study. Analysis set will consist of participants with HCV chronic infection who are registered at the Brazilian reference centers and meet all the inclusion criteria and have sufficient information to identify the diagnosis of chronic HCV infection with identification of genotype. The study related data will be collected from the medical records in the predesigned electronic Case Report Form (eCRF).
Study Design
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Study Type : Observational
Actual Enrollment : 1649 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Protocol to Describe the Actual Situation of Hepatitis C Treatment in Brazil
Actual Study Start Date : April 12, 2016
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Group 1
Brazilian participants with Hepatitis C virus (HCV) chronic infection who are registered at the Brazilian reference centers and meet all the inclusion criteria and have sufficient information to identify the diagnosis of chronic HCV infection with identification of genotype.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with chronic hepatitis C infection [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants.

  2. Date of last visit [ Time Frame: Day 1 ]
  3. Number of Participants with chronic hepatitis C infection Reported Based on City and States [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants.

  4. Number of Participants with chronic hepatitis C infection Based on precedence [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants.

  5. Mean Age of Participants with chronic hepatitis C infection [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants.

  6. Number of Males and Females with chronic hepatitis C infection [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants.

  7. Number of participants with chronic hepatitis C infection Reported Based on Race [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants.

  8. Mode of Hepatitis C virus (HCV) transmission [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants. Mode of HCV transmission route (unsafe injections, hemodialysis, infection drug use, blood transfusion, sexual transmission, vertical transmission, unknown, other) will be analysed by number of participants infected with HCV per transmission route.

  9. Duration of diagnosis of chronic hepatitis C infection [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants.

  10. HCV genotype and subtype [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants.

  11. Liver characteristics: Number of Participants with extra hepatic manifestations [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants. Presence or absence of extra hepatic manifestations (cryoglobulinemia, lymphoma, Sjogren syndrome, glomerulopathy, Porphyria cutanea tarda, liquen planus, diabetes mellitus, thyroiditis, arthralgia).

  12. Liver characteristics: Number of Participants with presence of comorbidities [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants. Presence of comorbidities (amount of alcohol ingestion, metabolic syndrome, hepatocellular carcinoma, organ transplantation, diabetes, immunodeficiency, renal insufficiency and dialysis, use of drugs) will be collected.

  13. Liver characteristics: Model for End-Stage Liver Disease (MELD) Score and Child Pugh score [ Time Frame: Day 1 ]
    MELD is a scoring system for assessing the severity of chronic liver disease. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).

  14. Liver characteristics: Number of Participants with Fibrosis based on Fibroscan [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants.

  15. Number of Participants with Coinfections [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants.

  16. HCV treatment status on Day 1: Percentage of participants receiving antiviral treatment [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants.

  17. HCV treatment status on Day 1: Causes of interruption in treatment [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants. Causes of interruption to antiviral therapy will be collected and reported.

  18. HCV treatment status on Day 1: Number of participants treated without Sustained Virological Response (SVR) [ Time Frame: Day 1 ]
    Data will be collected through medical records of the participants.

  19. Treatment regimen [ Time Frame: Day 1 ]
    The drugs used and time of treatment will be collected through medical records of the participants.

  20. Number of participants with Adverse Events (AEs) [ Time Frame: Day 1 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Analysis set will consist of participants with Hepatitis C virus (HCV) chronic infection who are registered at the Brazilian reference centers and meet all the inclusion criteria and have sufficient information to identify the diagnosis of chronic HCV infection with identification of genotype.
Criteria

Inclusion Criteria:

  • Participants with diagnosis confirmed with Hepatitis C infection being followed into the reference centers
  • There is no restriction on fibrosis stage or clinical liver disease
  • There is no restriction for comorbities or coinfections
  • Diagnosis of chronic HCV infection detected by anti-HCV (ELISA assays), HCV Ribonucleic acid (RNA) (polymerase chain reaction [PCR] reaction) with identification of genotype

Exclusion Criteria:

  • Male or female participant with age greater than or equal to 18 years
  • participating in another interventional clinical trial
  • Treated participants who achieved sustained Virological Response (SVR)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773394


Locations
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Brazil
Goiânia, Brazil
Porto Alegre, Brazil
Porto Velho, Brazil
Recife, Brazil
Rio Branco, Brazil
Rio De Janeiro, Brazil
Salvador, Brazil
Sao Paulo, Brazil
Sponsors and Collaborators
Janssen-Cilag Ltd.
Investigators
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Study Director: Janssen-Cilag Ltd. Clinical Trial Janssen-Cilag Ltd.
More Information
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Responsible Party: Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT02773394    
Other Study ID Numbers: CR107066
TMC435HPC4013 ( Other Identifier: Janssen-Cilag Ltd. )
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen-Cilag Ltd.:
Hepatitis C Virus
Observational
Brazil
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections